Step-by-Step IOPQ protocol and report templates for thawing in a controlled environment

Based on GxP industry standards / GAMP® 5 methodology

Master File

Enables incorporation of ThawSTAR® into clinical studies MAF on file with FDA (reference number MAF2643) containing information on all models of ThawSTAR the Master File for ThawSTAR® Automated Cell Thawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) under the reference number MAF2643. If you are submitting an investigational new drug (IND) application or a biologics license application (BLA) to the U.S. FDA, and need a cross-reference letter to our Master File, please contact us at regulatory@medcision.com.

ThawSTAR® Performance Data

ThawSTAR® AT6 Thaw Time Reproducibility

ThawSTAR® AT6 thaw time reproducibility using an optimized algorithm, thaw times are highly reproducible from unit to unit for each fill volume tested and from liquid nitrogen or dry ice temperatures. Thaw times for 17 pre-production AT6 units. 6 ml vials were filled with 2-6 ml of cryopreservation solution, and each volume was thawed in 17 units over 1 week of testing. Thaw times were about 50 s longer when starting from liquid nitrogen temperatures.

Ex-Vivo B Cells: Cell thawing with ThawSTAR vs. water bath

Post-thaw viability and consistency were evaluated using a total of 6 vials (2 each from 3 donors) containing ex vivo stimulated B cells, were frozen in a -80°C freezer using a CoolCell® cell freezing container and then stored in liquid nitrogen for two weeks. One vial from each donor was removed from LN2, placed into a ThawSTAR® CFT2 Transporter and thawed in a ThawSTAR CFT2 Instrument. The other vial from each donor was removed from LN2 and hand-carried to a water bath. The vials transported and thawed in the ThawSTAR transport and thawing system performed better in terms of cell viability and recovery.

ThawSTAR Cell Thawing System Case Studies

“Both of my teams solely use the ThawSTAR® system as their go to thawing device for thawing cells. It is second to none when it comes to efficiency, consistency and sterility. If we have high quality, robust cells, they tend to recover better, propagate better and, overall, perform better in assay. I look forward to using our ThawSTAR® system for many years to come.”